FDA Adverse Event
Death
Summary report: N
INTRODUCER SHEATH, 8 F
MDR report key: 12891
·
Received March 8, 1994
Report
- Report Number
- 12891
- Event Type
- Death
- Date Received
- March 8, 1994
- Date of Event
- February 12, 1994
- Report Date
- March 8, 1994
- Manufacturer
- DAIG CORP.
- Product Code
- DYB
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
DISLODGEMENT OF SIDE ARM FROM HUB OF 8 F VENOUS SHEATH RESULTING IN LOSS OF APPROX 2 UNITS OF BLOOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTRODUCER SHEATH, 8 F | INTRODUCER SHEATH, 8 F | DYB | DAIG CORP. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Death| L |